Protocol Implementation Meetings

Leukemia Protocol

On July 14th, a meeting of the investigators and data managers involved in the protocol entitled, “The Treatment and Characterization of Acute Lymphoblastic Leukemia in Children, Adolescents and Young Adults” was held by video-conference. INCTR personnel joined the conference via the National Cancer Institute's Liaison Office in Brussels which was linked to both the Sir Ganga Ram Hospital in Delhi and the Tata Memorial Hospital in Mumbai, where our Indian colleagues gathered. Four institutions in India will participate in this study. These institutions are the All India Institute of Medical Sciences, Delhi, Cancer Institute (WIA), Chennai, the Jaslok Hospital, Mumbai and the Tata Memorial Hospital, Mumbai. The objectives of this meeting were to review the protocol and procedures for data management and data quality assurance prior to the initiation of the study. During the meeting, it was agreed to begin patient accrual on August 1st. It was also decided that a training workshop for the data managers and data manager would be held in November, 2004 in order to discuss issues pertaining to basic data management and to study specific data management procedures. This training will be interactive and will include “hands on” experience in the use of the remote data entry system, developed for the study by Capitol Technology Information Services, Inc in collaboration with INCTR Clinical Trials Office staff.

African Burkitt's Lymphoma Protocol

An implementation meeting for the investigators and data managers participating in the protocol, “The Treatment and Characterization of Burkitt's Lymphoma in Africa” was held on August 12th and 13th. The meeting was hosted by Twalib Ngoma, one of the participating investigators, and his staff at the Ocean Road Cancer Institute in Dar-es-Salaam, Tanzania. INCTR staff were joined by other investigators and their respective staffs representing University of Ibadan, Ibadan, Nigeria, the Obafemi Awolowo University Teaching Hospital, Ile-Ife, Nigeria, the University of Nairobi's Kenyatta National Hospital, Nairobi, Kenya and Mbarara University of Science and Technology, Mbarara, Uganda. During the course of the meeting, the protocol document was reviewed in-depth, with particular attention being paid to patient eligibility, pre-treatment evaluation, and the treatment itself. In addition to the protocol, the case report forms (i.e., data collection forms) were reviewed in detail and instructions for completing the forms were provided. A demonstration of the data entry system was given and the procedures for data submissions discussed. The role of the study committee, comprised of the principal investigators, was agreed upon. Their responsibilities will include monitoring protocol progress and identifying the need for protocol amendments. In addition to the study committee, INCTR will also monitor the quality of data and organize central pathology review. It was agreed that patient accrual would begin on August 16th.

Second Meeting of Grupo Mexicano de Retinoblastoma (GMR)

The GMR held its second meeting, again sponsored by INCTR, in Hidalgo, Mexico, on 26th and 27th August. Delegates, mostly pediatric oncologists and ophthalmologists, from 19 centers throughout Mexico attended. The group decided to unify Mexican protocols for retinoblastoma, and to treat, if possible, all patients with bilateral disease at a single center.

Second Grupo Mexicano de Retinoblastoma meeting at Hidalgo.

Seminar on the Need for a Multidisciplinary Approach in Pediatric Oncology

A multidisciplinary educational seminar was held simultanously with the Workshop on Clinical Trials in Sao Paolo in early September. Organized by INCTR Brasil and the Sociedade Brasileira de Oncologia Pediátrica, the goal was to emphasize the importance of interdisciplinary team work from diagnosis to cure, or terminal care, in the support of cancer patients and their families. The highly successful meeting was attended by psychologists, social assistants, nurses, occupational therapists, physiotherapists, audiologists, teachers and other health professionals, and was the first INCTR meeting of its kind.